MAUDE Adverse Event Report: MEDTRONIC, INC. REVEAL LINQ; DETECTOR AND ALARM, ARRHYTHMIA

Model Number LNQ11

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Unspecified Infection (1930); Pain (1994); Pocket Erosion (2013); Dizziness (2194); Blood Loss (2597)

Event Date 03/28/2017

Event Type  Injury  

Manufacturer Narrative

This information is based entirely on journal literature.This event occurred outside the us.All information provided is included in this report.Multiple patients were noted in the article; however, a one to one correlation could not be made with unique product serial numbers.Patient information is limited due to confidentiality concerns.The gender of the baseline characteristics is male and the baseline age is 74 years old.Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.Request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: ¿complications after implantation of a new-generation insertable cardiac monitor: results from the loop study.¿ international journal of cardiology.2017; 241:229-234.Http://dx.Doi.Org/10.1016/j.Ijcard.2017.03.144.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was reviewed that contained information regarding insertable cardiac monitors (icms).Multiple patients were noted in the article; however, a one to one correlation could not be made with unique serial numbers with the available information provided.The author reported that there were seven (7) patients who had procedural dizziness.There were also fifteen (15) patients who showed infections, post-implant pain, ¿minor¿ bleeding, and hematomas; all of which were treated ¿conservatively,¿ or by suturing the wound.For these patients, the device was not explanted.There were nine (9) patients whose device was explanted for the following reasons: infection, post-implant pain, and pocket erosion.Eight (8) of these patients had a new device implanted.The status/location of the icm is unknown.Further follow up did not yet yield any additional information.No further patient complications have been reported as a result of this event.

• Brand Name: REVEAL LINQ
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6932369
• MDR Text Key: 88931238
• Report Number: 2182208-2017-01780
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K132649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LNQ11
• Device Catalogue Number: LNQ11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2017
• Initial Date FDA Received: 10/09/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 74 YR